Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation (Phase II)
Transcutaneous Spinal Stimulation
Central Nervous System Diseases+3
+ Nervous System Diseases
+ Spinal Cord Diseases
Treatment Study
Summary
Study start date: February 19, 2024
Actual date on which the first participant was enrolled.This study is exploring a treatment method called transcutaneous spinal stimulation (TSS) to help people with spasticity, which is a condition where muscles are continuously contracted, causing stiffness or tightness. TSS is a noninvasive approach that involves applying electrical stimulation on the skin over the lower back and stomach. This method has been found to reduce muscle tightness without the side effects that often accompany drug therapies. However, the ideal frequency of electrical pulses for the most effective results is still unknown. This study aims to find out which frequency works best by comparing three different ones, with the hope of improving treatment for those with spasticity and possibly reducing related pain and improving muscle strength. Participants in the study will undergo a session where their levels of muscle stiffness, strength, and pain are measured before and after receiving 30 minutes of TSS. The stimulation involves electrical pulses delivered through the skin, which is painless and does not require any surgical procedures. Researchers will evaluate the effects of different frequencies of electrical pulses on the nerves to determine their impact on reducing spasticity, alleviating pain, and enhancing muscle function. This study is important because it could lead to a more effective, non-drug treatment option for people dealing with these symptoms.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location